OsciPulse D-dimer Pilot Trial

NCT06477016 | Recruiting FDA Device

• 1 other identifier: OSC-VTE-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pilot, randomized, non-blinded clinical trial to generate preliminary data to evaluate the impact of the OsciPulse system on serum d-dimer levels compared to standard of care intermittent compression therapy for DVT prophylaxis in patients admitted in the neuro ICU or intermediate neurological care unit with acute ischemic stroke.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Change in serum d-dimer levels.

  Relative change in serum d-dimer levels for each subject from baseline to Day 7 or discharge

  7 days

Secondary Outcomes (2)

• Tolerability of the OsciPulse device in the stroke population

  7 days

• Safety of the OsciPulse device in the stroke population

  7 days

Study Arms (2)

Group A-OsciPulse System

EXPERIMENTAL

Patients admitted to the neuro intensive care unit or intermediate neurological care unit with a diagnosis of ischemic stroke randomly assigned to Group A.

Device: OsciPulse

Group B- Standard Reference Therapy

ACTIVE COMPARATOR

Patients admitted to the neuro intensive care unit or intermediate neurological care unit with a diagnosis of ischemic stroke randomly assigned to Group B.

Device: Intermittent Pneumatic Compression

Interventions

OsciPulse DEVICE

Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.

Group A-OsciPulse System

Intermittent Pneumatic Compression DEVICE

Non-invasive device that provides rapid pulses of compression of the calves to modify venous blood flow patterns in immobilized persons.

Group B- Standard Reference Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult aged ≥ 18 years old
• Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
• \< 24 hours from last known normal or treating-hospital admission.
• NIH stroke score ≥5
• Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores)
• Prescribed mechanical therapy for DVT prophylaxis.

You may not qualify if:

• \. Inability or contraindication to applying IPC to both legs such as:
• Evidence of acute bone fracture in lower extremities
• Acute burns in the lower extremities, lacerations, ulcers, active skin infection or dermatitis, in the lower extremities at the site of IPC placement
• Acute ischemia or severe peripheral vascular disease in the lower extremities as evidenced by cyanotic, cool, pulselessness.
• Amputated foot or leg on one or two sides
• Compartment syndrome (acute injury causing swelling and ischemic injury)
• Severe lower extremity edema (+4 edema as documented by clinical team)
• Acute deep vein thrombosis 2. Subjects who received thrombolytic therapy for their stroke 3. Known pregnancy or within 6 weeks of postpartum period. 4. Limitation of life support, life expectancy \< 7 days, or in hospice care 5. A head-unit is unavailable within 24 hours of study enrollment. 6. At the discretion of the attending physician and / or clinical team, the subject's participation in the study is believed not to be in the best interest of the subject.

Sponsors & Collaborators

• University of Pennsylvania: lead
• OsciFlex LLC: collaborator

Study Sites (1)

HUP Neurology Dept. of Stroke and Neurocritical Care- University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Intermittent Pneumatic Compression Devices

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Steven Messe, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Messe, MD

CONTACT

215-662-3363; Steven.Messe@pennmedicine.upenn.edu

Sophia Bautista

CONTACT

215-662-3487; Sophia.Bautista@Pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single site, randomized open label two arm study.

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 27, 2024
• Study Start: February 12, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)